Pexarite

Pemetrexed hemipentahydrate

In combination w/ cisplatin for chemotherapy naïve patients w/ unresectable malignant pleural mesothelioma; 1st-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. As monotherapy for maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy; 2nd-line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology.

IV infusion Administer over 10 min on 1st day of each 21-day cycle. Premed: Oral dexamethasone 4 mg bid a day prior to, on the day of, & the day after pemetrexed administration. Oral folic acid or multivit containing folic acid (350-1,000 mcg) daily at least 5 doses during 7 days preceding 1st dose of pemetrexed, & continue during full course of therapy & for 21 days after last dose of pemetrexed. Vit B₁₂ 1,000 mcg IM in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter. May administer subsequent vit B₁₂ inj on same day as pemetrexed. In combination w/ cisplatin 500 mg/m² + cisplatin 75 mg/m² over 2 hr approx 30 min after pemetrexed completion. Monotherapy for NSCLC after prior chemotherapy 500 mg/m².

Hypersensitivity. Concomitant yellow fever vaccine. Lactation.

Discontinue therapy if patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions, or immediately if Grade 3 or 4 neurotoxicity is observed. Withhold treatment if patient develops non-haematologic toxicities ≥Grade 3 (excluding neurotoxocity). Monitor patients for myelosuppression during therapy & not to be given until ANC returns to ≥1,500 cells/mm³ & platelet count returns to ≥100,000 cells/mm³; acute tubular necrosis, decreased renal function & signs & symptoms of nephrogenic diabetes insipidus (eg, hypernatraemia). Bone marrow suppression manifested by neutropenia, thrombocytopenia & anaemia (or pancytopenia). Skin reactions in patients not pre-treated w/ corticosteroid. Severe dehydration; administer adequate anti-emetic & appropriate hydration prior to &/or after receiving treatment w/ cisplatin. Serious renal events including acute renal failure; nephrogenic diabetes insipidus & renal tubular necrosis when used as monotherapy or w/ other chemotherapeutic agents. Patients w/ pre-existing CV risk factors. Consider drainage of 3rd space fluid collection prior to treatment. Not recommended to use concomitantly w/ live attenuated vaccines. Radiation pneumonitis in patients treated w/ radiation prior, during, or subsequently to pemetrexed therapy. Radiation recall in patients who received RT wk or yr previously. May affect ability to drive or operate machines. Not recommended to use in patients w/ CrCl <45 mL/min. Interrupt NSAID w/ long elimination t_½ for at least 5 days prior to, on the day of, & at least 2 days following administration in patients w/ mild to moderate renal insufficiency eligible for pemetrexed therapy. Avoid NSAIDs eg, ibuprofen & ASA (>1.3 g daily) for 2 days before, on the day of, & 2 days following administration in patients w/ mild to moderate renal insufficiency. Hepatic impairment eg, bilirubin >1.5x ULN &/or aminotransferase >3x ULN (hepatic metastases absent) or >5x ULN (hepatic metastases present). Women of childbearing potential must use effective contraception during treatment. Sexually mature males should not father a child during treatment & up to 6 mth thereafter, & must use effective contraception or abstinence; seek counselling on sperm storage before starting treatment. Pregnancy. Discontinue breastfeeding during therapy. No relevant use in childn. 500 mg: Patients on restricted Na diet.

Infection, pharyngitis; neutropenia, leukopenia, decreased Hb; stomatitis, anorexia, vomiting, diarrhoea, nausea; rash, skin exfoliation; decreased CrCl, increased blood creatinine; fatigue. Sepsis; febrile neutropenia, decreased platelet count; hypersensitivity; dehydration; taste disorder, peripheral motor & sensory neuropathy, dizziness; conjunctivitis, dry eye, increased lacrimation, keratoconjunctivitis sicca, eyelid oedema, ocular surface disease; cardiac failure, arrhythmia; dyspepsia, constipation, abdominal pain; increased ALT & AST; hyperpigmentation, pruritus, erythema multiforme, alopecia, urticaria; renal failure, decreased GFR; pyrexia, pain, oedema, chest pain, mucosal inflammation; increased γ-glutamyl transferase. SJS, TEN.

Potential delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretics, platinum compd, cyclosporin); tubularly secreted substances (eg, probenecid, penicillin). Decreased elimination w/ high doses of NSAIDs eg, ibuprofen (>1,600 mg daily) & ASA (≥1.3 g daily). Concomitant use w/ piroxicam or rofecoxib; oral anticoagulants; live attenuated vaccines.

Cytotoxic Chemotherapy

L01BA04 - pemetrexed ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.

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